Package leaflet: Information for the patient

JEVTANA® 60 mg

concentrate and solvent for solution for infusion

cabazitaxel

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

What is in this leaflet:

1. What JEVTANA is and what it is used for
2. What you need to know before you are given JEVTANA
3. How to use JEVTANA
4. Possible side effects
5. How to store JEVTANA
6. Contents of the pack and other information

2. What you need to know before you are given JEVTANA

Do not use JEVTANA if:

you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or to any of the other excipients of the formulation including polysorbate 80,

the number of your white blood cells is too low (neutrophil counts less than or equal to 1,500 /mm3),

you have abnormal liver function,

you have recently received or are about to receive a vaccine against yellow fever.

You should not be given JEVTANA if any of the above apply to you. If you are not sure, talk to your doctor before having JEVTANA.

Warnings and Precautions

Before each treatment with JEVTANA, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive JEVTANA.

Tell your doctor immediately if:

you have fever. During treatment with JEVTANA, it is more likely that your white blood cell count may be reduced. Your doctor will monitor your blood and general condition for signs of infections. He/she may give you other medicines to maintain the number of your blood cells. People with low blood counts can develop lifethreatening infections. The earliest sign of infection may be fever, so if you experience fever, tell your doctor right away.

you have ever had any allergies. Serious allergic reactions can occur during treatment with JEVTANA.

you have severe or long lasting diarrhoea, you feel sick (nausea) or you are being sick (vomiting). Any of these events could cause severe dehydration. Your doctor may need to treat you.

you have feeling of numbness, tingling, burning or decreased sensation in your hands or feet.

you have any bleeding problems from the gut or have changes in the colour of your stool or stomach pain. If the bleeding or pain is severe, your doctor will stop your treatment with JEVTANA. This is because JEVTANA may increase the risk of bleeding or developing holes in the gut wall.

you have kidney problems.

liver problems occur during the treatment.

you experience any significant increase or decrease in daily urinary volume.

If any of the above applies to you, tell your doctor immediately. Your doctor may reduce the dose of JEVTANA or stop the treatment.

Other medicines and JEVTANA

Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription. This is because some medicines can affect the way JEVTANA works or JEVTANA can affect how other medicines work. These medicines include the following:

Talk to your doctor before getting vaccinations while you are receiving JEVTANA.

Pregnancy, breast-feeding and fertility

Use a condom during sex if your partner is or could become pregnant. JEVTANA could be present in your semen and may affect the foetus. You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because JEVTANA may alter male fertility.

JEVTANA should not be used in pregnant women or women of childbearing age not using contraception.

JEVTANA should not be used during breast feeding.

Driving and using machines

You may feel tired or dizzy when having this medicine. If this happens, do not drive or use any tools or machines until you feel better.

JEVTANA contains ethanol (alcohol)

This medicine contains 15% v/v ethanol (alcohol), equivalent to 14 ml of beer or 6 ml of wine. This medicine may be harmful for those suffering from alcoholism.

To be taken into account if you are in a high risk group such as patients with liver disease, or epilepsy.

feeling of numbness, tingling, burning or decreased sensations in hands and feet

dizziness

headache

decrease or increase in blood pressure

uncomfortable feeling in the stomach, heart burn or belching

stomach pain

haemorrhoids

muscle spasm

painful or frequent urination

urinary incontinence

kidney disease or problems

sore in the mouth or on lips

infections or risk of infections

high blood sugar

low blood potassium

mental confusion

feeling anxious

abnormal feeling or loss of sensation or pain in hands and feet

ringing in the ear

trouble with balance

rapid or irregular heartbeat

blood clot in the leg

skin feeling hot or flushed

pain in mouth or throat

rectal bleeding

redness of the skin

muscle discomfort, aches or pain

swelling of the feet or legs

chills.

Reporting of side effects

United Kingdom

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via

Yellow Card Scheme

Website:www.mhra.gov.uk/yellowcard

Ireland

Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage.

A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’, in addition to the traditional post-paid ‘yellow card’ option.

FREEPOST
Pharmacovigilance Section
Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel:+353 1 6764971

Fax:+353 1 6762517

Website:www.imb.ie

e-mail:imbpharmacovigilance@imb.ie

Malta

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via

6. Contents of the pack and other information

What JEVTANA contains

The active substance is cabazitaxel. One ml of concentrate contains 40 mg cabazitaxel.

Each vial of concentrate contains 60 mg cabazitaxel.

The other ingredients are polysorbate 80 and citric acid in the concentrate, and ethanol 96% and water for injections in the solvent.

Note: Both the JEVTANA 60mg/1.5ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83ml) and the solvent vial (fill volume: 5.67ml) contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10mg/ml cabazitaxel.

What JEVTANA looks like and contents of the pack

JEVTANA is a concentrate and solvent for solution for infusion (sterile concentrate). The concentrate is a clear yellow to brownish yellow oily solution.

The solvent is a clear and colourless solution.

One pack of JEVTANA contains:

One single-use vial of 1.5 ml (nominal volume) concentrate in a clear glass vial closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip off cover.